The US Food and Drug Administration (FDA) has approved tafasitamab-cxix, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
The approval marks the first CD19- and CD20-targeted immunotherapy combination approved by the FDA for adult FL patients.
The approval was based on data from the pivotal, randomized, double-blind, placebo-controlled phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab-cxix in combination with rituximab and lenalidomide in adult patients with relapsed or refractory FL.
Patients receiving tafasitamab-cxix in combination with rituximab and lenalidomide in the inMIND trial achieved a median progression-free survival (PFS) of 22.4 months compared to 13.9 months in the control arm (hazard ratio: 0.43; P<0.0001). The PFS benefit was consistent across prespecified patient subgroups, including number of previous lines of therapy.
This is the second approved indication for tafasitamab-cxix in the United States. In July 2020, tafasitamab-cxix in combination with lenalidomide received FDA approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
“The FDA approval of [tafasitamab-cxix] in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease,” said Christina Poh, MD, assistant professor of medicine at the University of Washington and Fred Hutchinson Cancer Center, in a press release from Incyte, the drug’s manufacturer.
